About Us

Rubicon’s Mission and Technologies

Rubicon’s mission is to develop novel, practical targeted therapies that will greatly benefit the patient. Rubicon is developing two platform technologies: Fv-Hsp72 for acute indications and Modified Annexin for cancer.

Fv-Hsp72 is a powerful targeted cytoprotectant which can directly deliver Hsp72 into stressed and dying cells in order to salvage them from death. Our primary indication is myocardial infarction and we believe Fv-Hsp72 will help reduce cellular damage to the heart, thereby improving heart function and reducing morbidity. Other indications include acute lung injury and stroke.

Our Modified Annexin program uses Annexin A5, a natural high-affinity phosphatidylserine (PS)-binding protein discovered by Dr. Chris Reutelingsperger at Maastricht University. Dr. Reutelingsperger modified the annexin so that it will not internalize into the cell, which is the normal physiological response for annexin binding to PS. Phosphatidylserine is exposed on the surface of solid tumors and their blood vessels within the tumor microenvironment, but not on healthy cells. Rubicon’s Modified Annexin is able to deliver powerful anti-cancer compounds to a common target found on the surface of tumors and the tumor vasculature.

With a strong, experienced core team and world class collaborators, Rubicon is well positioned to develop our two leading-edge platform technologies.

Rubicon Biotechnology
26212 Dimension Drive, Ste. 260
Lake Forest, CA 92630
Phone: 949-215-2756

Co-Founders and Management Team

Richard A. Richieri, Chief Operations Officer
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Richard A. Richieri

Main responsibility at Rubicon: Richard Richieri is responsible for the process development and manufacturing of Rubicon’s drug candidates.

Mr. Richieri has extensive experience in cGMP manufacturing, process development and project management in the biotech industry. He has spent over 25 years designing, developing and optimizing manufacturing processes for biologic drugs.

He received his Bachelor’s degree in Chemical Engineering from the University of California, Los Angeles (UCLA) and his Master’s Degree in Chemical Engineering from the University of California, San Diego (UCSD). As part of his Master’s program, he studied how modifications to the cell cycle can improve monoclonal antibody production; an expertise that served him well when he began his industry career working at Xoma manufacturing antibodies for clinical trials using microbial and mammalian cell-based processes.

In 1996, he joined Peregrine Pharmaceuticals and worked on process engineering for each one of the company’s clinical antibody programs. In 2002, Peregrine launched Avid Bioservices, a contract manufacturing subsidiary. During Avid’s formative years, Mr. Richieri, as Senior Vice President of Bioprocess Development and Manufacturing, was responsible for attracting many new clients to utilize the company’s contract development and manufacturing services. He provided oversight in all aspects of the development and production process for both American and European clients dealing with FDA and EMA directives regarding manufacturing compliance.

During his tenure, Mr. Richieri also helped Avid diversify its production capabilities to include several large stainless steel bioreactor units, as well as the more agile single use disposable units. He led comparative studies to evaluate the system performance of both types of bioreactors and presented these results at major conferences as case studies, making Mr. Richieri a recognized authority on disposable manufacturing and cost-effective biologics production.

Since 2011, Mr. Richieri has been acting as a consultant to the pharmaceutical industry, including being named as a Samsung Global Advisor for their biosimilar program and as acting head of biologics production at Syngene International.

Missag H. Parseghian, PhD, Chief Scientific Officer
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Missag H. Parseghian, PhD

Main responsibility at Rubicon: Dr. Missag Parseghian is responsible for the protein characterization, assay development and pre-clinical animal studies of Rubicon’s drug candidates.

He received his Bachelor’s degree in Biology from the University of California, Los Angeles (UCLA); his Doctorate in Molecular Biology and Biochemistry from the University of California, Irvine; and conducted post-graduate work in collaboration with Los Alamos National Laboratory.

Before joining Rubicon, Dr. Parseghian was Vice President of Research & Development at Stonsa Biopharm, where he managed the company’s programs in cardiology and oncology. During his tenure at Stonsa, he filed a patent application with fellow inventors describing a new cardiovascular imaging agent while, simultaneously, conducting business development activities in Russia, China, Taiwan, Korea and Japan. Prior to Stonsa, Dr. Parseghian lead the TNT, Cotara® and VEA programs at Peregrine Pharmaceuticals, where he started as a Research Scientist in 1997 and was appointed Senior Director of R&D in 2007. Cotara® is a radiolabeled antibody and the VEAs are fusion antibodies, hence, each of these programs added an extra dimension of technical complexity to the antibody programs that he managed. During this period, he was responsible for assay development, antibody engineering and characterization, radiolabeling optimization, as well as new protein purification methods to remove antigens that might “hitchhike” on their respective antibodies.

Dr. Parseghian has helped advance the fields of chromatin biology and epigenetics by conducting ground breaking studies on the distribution of linker histone proteins in actively transcribed regions of the cell nucleus and comparing them to regions lacking gene expression, such as the centromeres and telomeres on a chromosome. He was also able to explain how cellular aging could lead to an attenuation of gene expression as an organism gets older and how that affects cellular responses to stressful conditions with age.

Dr. Parseghian is a member of the American Association for Cancer Research and the American Heart Association. He has continued to actively publish and lecture in the areas of antibody engineering and purification; chromosome and chromatin structure; gene regulation; nuclear proteins and their targeting in cancer and cardiovascular therapies. Links to his original research articles and reviews published in the scientific literature can be accessed at PubMed , ResearchGate and Google Scholar Citations. A list of publications and patents can also be found on LinkedIn.

Glenn T. Reynolds, MD, Chief Medical Officer
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Glenn Reynolds

Glenn T. Reynolds, MD

Main responsibility at Rubicon: Dr. Glenn Reynolds is a practicing interventional cardiologist and is responsible for designing clinical trials for Rubicon’s drug candidates.

Glenn Reynolds MD began his academic career at the Boston Latin School where he studied advanced mathematics and sciences and received the Benjamin Franklin Medal awarded to the top graduates. He pursued a major in Biology at Yale, followed by graduate study of plant and fungal derived molecules and immunology at Harvard. He studied platelets at Harvard Medical School and worked with the MIT Chemical Engineering Department developing polyethers and polyols for surgical applications. Glenn studied protein purification and enzyme kinetics and mechanism of action of thyroxine deiodinase at Boston University. He was responsible for development of cell separation techniques from blood and bone marrow at the Naval Blood Research Lab, and studied biochemical effects of light on whole retina preparations at the Massachusetts Eye and Ear Infirmary while earning his MD degree at the Boston University School of Medicine.

During residency in Internal Medicine at the University of California in Irvine, he studied cardiac exercise physiology, and was invited to the faculty as Chief Resident. Dr. Reynolds undertook a fellowship in Cardiovascular Diseases at UCLA, where he worked with Amgen to develop a rabbit model to test the anti-proliferative effects of their anti-sense drug, and with Scimed to develop a model to assess the impact of small particles on myocardium in pigs and to test a novel catheter to deliver drugs to injured vascular endothelium. He published a surgical technique to record and display venograms to guide placement of pacemaker leads, known as roadmapping. He was a research coordinator and principal investigator for the EPIC trial of abciximab (Reopro), a biologic drug still in use for acute coronary syndromes (Centocor, Lilly).

Dr. Reynolds finished his formal education studying Interventional Cardiology at the Arizona Heart Institute, which permitted participation in early trials of the Palmaz-Schatz coronary stent (Johnson & Johnson), the first and subsequent generations of endoluminal vascular grafts, including first use of an endoluminal stent graft in a coronary application, and testing of novel angioplasty catheters and guidewires (Scimed, Advanced Cardiac Systems) and thrombolytic drugs (Genentech).

Dr. Reynolds is Board Certified and has practiced general and interventional cardiology at rural and urban practices and hospitals, large and small, including Boswell Hospital, a participant in the GUSTO cardiology thrombolytic trials and home of the Sun Health Research Institute, and the Arizona Heart Institute and Heart Hospital.

Strategy

Operationally, Rubicon’s strategy is to maintain a small internal core team to manage and approve various QA, regulatory and technical tasks with our vetted network of CROs, CMOs and consultants. We will oversee the strategic and day-to-day challenges ahead; all in accordance with regulatory guidelines. Our internal capabilities are complemented by an outstanding group of scientific advisors located in North America and Europe.

We will manage the cGMP production of our clinical candidates at our CMO and will review and approve the analytical testing and clinical protocols. Our goal is to ensure that our external resources are organized and working together to produce a harmonized process.

Our objective is to have a complete program package (intellectual property, GMP supply chain, regulatory documents, etc.) available to potential partners that would meet the high expectations of suitable licensees.

 

Collaborations


CounterACT is the National Institutes of Health (NIH) interdisciplinary program for development of new and improved medical countermeasures designed to prevent, diagnose and/or treat the conditions caused by potential and existing chemical threat agents.

Rubicon was selected in 2013 to join the CounterACT network in conjunction with a multi-year award to test one of our targeted heat shock proteins (Fv-Hsp70) for the treatment of pulmonary intoxication in the event of an industrial accident or the release of a chemical warfare agent. At present, Rubicon has received two grants totaling over $650K.


Maastricht University is one of the Netherlands’ leading research institutions and home to Chris Reutelingsperger, discoverer of Annexin A5, the most avid phosphatidylserine (PS)—binding protein found in nature.

A modified Annexin A5 created in Dr. Reutelingsperger’s lab is being adapted by the Rubicon team for targeting of extracellularly-exposed PS in the tumor microenvironment. A direct PS-binder, Annexin A5 holds great promise as an immunotherapeutic agent.


MosaMedix B.V. builds on work from Dr. Reutelingsperger and his group. The company’s primary goal is the design, construction and manufacture of new Annexin A5 derivatives for clinical use in the monitoring and treatment of disease.

On July 7th 2015, Rubicon obtained an exclusive world-wide license from MosaMedix for the use of non-internalizing Annexin A5 variants as a targeted therapeutic agent against any solid tumor. Rubicon is currently conducting efficacy studies on several versions of the molecule to identify a clinical candidate.


The Mount Sinai School of Medicine is one of our nation’s premier research hospitals and home to Dr. Jagat Narula, Professor of Medicine, Cardiology and Radiology. In 2015, he received the American College of Cardiology’s Distinguished Scientist Award.

At Mount Sinai, Rubicon tests the Fv-Hsp72 technology for the treatment of ischemia/reperfusion damage following a myocardial infarction using the animal models developed by Dr. Narula and his research team.


MRIGlobal is a non-profit research institute that conducts programs in the areas of national security and defense for several government agencies including the Dept. of Defense and the NIH.

As part of our defense-countermeasures programs, Rubicon has contracted MRIGlobal to conduct animal studies requiring high-containment facilities. All studies using toxic inhalants, including potential chemical warfare agents, are run at MRIGlobal given the expertise of their staff in handling these materials.


The National Cancer Institute (NCI) is the federal government’s principal agency for cancer research and is an integral part of the NIH.

The NCI awarded Rubicon an SBIR grant in 2015 of nearly $300K to demonstrate proof-of-principle and to identify a suitable Annexin A5—derivative for development as an immunotherapeutic agent.


The National Heart, Lung and Blood Institute (NHLBI) is the NIH’s primary agency for cardiovascular research.

The NHLBI awarded Rubicon an SBIR grant in 2014 of nearly $225K to demonstrate the efficacy of the Fv-Hsp70 technology in preventing reperfusion damage following a myocardial infarction. And in 2015, Rubicon was selected as an NHLBI showcase company at its Innovation Conference.


 

The chemists at Seacoast Science are leaders in the development of chemical sensors and detection devices for the military and homeland security.

Seacoast has been assisting Rubicon in the area of defense-countermeasure technologies since 2013.


In less than 50 years, the University of California, Irvine (UCI) has achieved national recognition for its translational research. UCI was a leader in forging relationships between university researchers and local entrepreneurs before her sister institutions.

Rubicon works with biostatisticians at UCI in the planning of animal studies. They also provide independent confirmation of the statistical significance of the data before submission for publication.


UCLA

The University of California, Los Angeles (UCLA) is one of our nation’s top research universities and home to the inventors of the targeted heat shock protein technology: Drs. Richard Weisbart and Robert Nishimura.

Rubicon continues to work closely with both inventors in the development of the Fv-Hsp72 technology platform for myocardial infarction, stroke and pulmonary intoxication.


Vanderbilt University and its School of Medicine are home to Dr. Andries Zijlstra, a leading expert on cancer metastasis.

Rubicon is testing various Annexin A5 constructs in several tumor models with the help of Dr. Zijlstra and his team. His invaluable expertise is helping Rubicon screen for the optimal immunotherapeutic construct that can be advanced into clinical trials.


The Dept. of Veterans Affairs (VA) has several hospitals throughout the country that are affiliated with major research universities. Dr. Weisbart and Dr. Nishimura, inventors of the Fv-Hsp72 technology, are affiliated with the VA through UCLA.

Rubicon obtained an exclusive license from the VA in 2015 for the use of heat shock proteins conjugated to the 3E10 antibody, an intracellular transporter. The 3E10 antibody is the targeting agent that allows penetration of heat shock proteins into cells in danger of apoptosis.